NCT06258876: PrEPInTheCity

Human Immunodeficiency Virus Pre-exposure Prophylaxis Program in General Practice

Not yet recruiting Last updated 14 February 2024

What this trial tests

trial testing PrEP in general practice in Human Immunodeficiency Virus in 400 participants. Not yet recruiting.

Timeline

15 February 2024

Primary endpoint
15 February 2027

15 February 2027

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	400
Start date	15 February 2024
Primary completion	15 February 2027
Estimated completion	15 February 2027

Drugs / interventions tested

• PrEP in general practice

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 100, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Human Immunodeficiency Virus (HIV) epidemic persists in France, with approximately 6000 new cases per year. Various prevention tools against HIV exist, including condoms, regular testing, Post-Exposure Prophylaxis (PEP), HIV treatment for seropositive partners, single-use disposable injection equipment for drug use and pre-exposure prophylaxis (PrEP).

Continuous or on-demand PrEP with tenofovir disoproxil fumarate/emtricitabine has proven effective in reducing the risk of HIV infection. France was the first European country to authorize PrEP, leading to an unprecedented impact on seropositivity discovery rates in 2018, with a 7% decrease in new infections compared to 2017.

However, the effectiveness of PrEP can be hindered by challenges in retaining users within the healthcare system. According to the EPIPHARE report, which has been monitoring Truvada® or generic PrEP use since 2017, a substantial proportion of new users do not receive PrEP renewal in the first 6 months after initiation. Such early interruptions, increasing in frequency, affected around a quarter of individuals who initiated PrEP in the second half of 2021.

A recent study reported that these early interruptions have a significant detrimental impact on PrEP effectiveness in real life, especially among those under 30 years old and in socio-economic precarious situations.

The main barriers to PrEP adherence are multifactorial, including social precarity, limited PrEP access, and a low perception of HIV risk. To address this, in France, general practitioners have been authorized to issue initial PrEP prescriptions since June 1, 2021.

The future challenge is to increase PrEP use and optimize retention to combat the HIV epidemic, relying significantly on general medicine. The goal of our study is to broaden PrEP access by optimizing its initial prescription in general medicine and to assess user retention in PrEP care through the established partnership between general practitioners and patients.

The research will be conducted in collaboration between Saint Louis Hospital in the 10th arrondissement of Paris and general practitioners willing to participate in the study, located in the 3rd, 10th, 11th, 13th, and 19th arrondissements. Participating general practitioners may be in private practice, employed in health centers, or working in health houses.

As part of the study, general practitioners will receive training from the infectious diseases department of Saint-Louis and Lariboisière hospitals. This training will be both theoretical and practical, with the opportunity to attend initiation and follow-up PrEP consultations in the department. A dedicated phone line in the infectious diseases department of Saint Louis Hospital will be available for participating general practitioners seeking specialized advice. They will be encouraged to register as PrEP prescribers in their appointment scheduling software.

Patients will be informed of the study objectives and its process by the general practitioner, and their oral non-opposition will be collected.

Each inclusion consultation will last approximately 20-40 minutes, allowing the general practitioner to prescribe PrEP, conduct the usual care consultation, and collect clinical, demographic, socio-economic, lifestyle, medical history, and patient vaccination data on a dedicated data collection form.

The follow-up duration will be two years, with consultation frequency matching that of regular PrEP follow-ups, and data collection will occur at M6, M12, M18, and M24 using a dedicated data collection form.

Data collected during inclusion and follow-up consultations will be anonymized and integrated into the electronic Clinical Report Form. During each PrEP consultation (initiation and follow-up), general practitioners will provide patients with a PrEP prescription if the pre-PrEP biology report allows it (according to HAS (Haute Autorité de Santé) recommendations).

For patients who have not been attending consultations, a telephone survey will be offered to inquire about PrEP continuation and collect information on follow-up or reasons for stopping PrEP.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.